CLINICAL TRIAL

Brief Pain Teleconsult for Low Back Pain

Recruiting · 18+ · All Sexes · Salt Lake City, UT

This study is evaluating whether a telehealth approach can improve pain management for patients with chronic back pain.

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About the trial for Low Back Pain

Eligible Conditions
Chronic Pain · Low Back Pain

Treatment Groups

This trial involves 2 different treatments. Brief Pain Teleconsult is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 3 and have had some early promising results.

Experimental Group 1
Telehealth Physical Therapy
BEHAVIORAL
+
Brief Pain Teleconsult
BEHAVIORAL
Experimental Group 2
Telehealth Physical Therapy
BEHAVIORAL
+
Brief Pain Teleconsult
BEHAVIORAL

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Telehealth Physical Therapy
2020
N/A
~130

Eligibility

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
The text says that the age group is between 18-70 years old. show original
Can communicate in either English or Spanish. show original
I have visited an FQHC provider in the past 90 days. show original
Back pain has been an ongoing problem for at least the past 3 months, and has been a problem on at least half the days in the past 6 months
In order to receive telehealth sessions, you will need to have access to resources like a phone or a computer with 2-way video capabilities. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: baseline, 12-, 26- and 52-weeks
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 12-, 26- and 52-weeks
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: baseline, 12-, 26- and 52-weeks.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Brief Pain Teleconsult will improve 7 secondary outcomes in patients with Low Back Pain. Measurement will happen over the course of across 52 week follow-up.

opioid use
ACROSS 52 WEEK FOLLOW-UP
Prescription opioid use across the 52-week follow-up will be examined from EHR noting number of prescriptions and days of use.
ACROSS 52 WEEK FOLLOW-UP
PEG-3
BASELINE, 26- AND 52-WEEKS
The PEG-3 measure includes 3 items evaluating 1) pain severity, and interference of pain with 2) enjoyment and 3) general activity. Item response options range from 0-10. The PEG-3 score is expressed as the mean of all item scores with higher scores indicating greater pain impact
BASELINE, 26- AND 52-WEEKS
Pain Self-Efficacy
BASELINE, 12-, 26- AND 52-WEEKS
The PSEQ-4 is a short form questionnaire evaluating an individual's confidence in performing activities despite pain
BASELINE, 12-, 26- AND 52-WEEKS
Global Impression of Change
BASELINE, 12-, 26- AND 52-WEEKS
The single-item PGIC assesses participants' of change following treatment based on the question: "Since my treatment, my pain is…" with Likert scale response options ranging from (0) "very much worse" to (6) "very much improved".
BASELINE, 12-, 26- AND 52-WEEKS
Pain Catastrophizing
BASELINE, 12-, 26- AND 52-WEEKS
The PSC-6 is a short-form questionnaire evaluating an individual's negative cognitive-affective response to anticipated or actual pain
BASELINE, 12-, 26- AND 52-WEEKS
Physical Function
BASELINE, 12-, 26- AND 52-WEEKS
The PROMIS short form 6b for physical function uses fixed items from the PROMIS physical function item bank to provide a T-score with population mean = 50 (sd=10).
BASELINE, 12-, 26- AND 52-WEEKS
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Who is running the study

Principal Investigator
J. F.
Prof. Julie Fritz, Distinguished Professor
University of Utah

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people get low back pain a year in the United States?

More than 400,000 American adults will seek treatment for low [back pain](https://www.withpower.com/clinical-trials/back-pain) a year. Patients treated for low back pain continue to have high rates of chronic, disabling pain for up to 5 and 10 years after their index episode of low back pain.

Anonymous Patient Answer

What causes low back pain?

There is no single cause of a specific type of low [back pain](https://www.withpower.com/clinical-trials/back-pain), but the strongest evidence suggests that risk factors for back pain include biological factors (such as family history), psychological factors (such as anxiety or depression), and behavioral factors (such as smoking). Treatment options (including physical and psychological) are available for most people with low back pain. There is considerable evidence that some low back pain is not caused by a particular type of disease, but rather it is a ‘-op-ional’ pain which can be related to other conditions such as muscle or joint pain. There is little evidence that alternative therapies, such as massage and chiropractic, have good clinical outcomes for the treatment of low back pain.

Anonymous Patient Answer

What are the signs of low back pain?

Low [back pain](https://www.withpower.com/clinical-trials/back-pain) is a common condition in primary care. Pain may be intermittent or fluctuate frequently, and it is usually worse at night or with lying down. Low back pain does not occur in isolation but is frequently accompanied by additional symptoms such as headache, fever, poor sleep, and diminished general well-being. Pain may be relieved by lying down or sitting up to alleviate the pressure placed on the spine. Low back pain can also be caused by the other signs and symptoms of spinal stenosis, such as the onset of sciatica (typically after age 40). Low back pain from spinal stenosis is often misdiagnosed as sciatica, but is a separate condition.

Anonymous Patient Answer

What is low back pain?

In the USA, low [back pain](https://www.withpower.com/clinical-trials/back-pain) (LBP) is the most common musculoskeletal disorder among working adults. The rate of admission due to LBP among US workers is estimated to be about 1.9-2.1 million cases per year due to LBP. LBP is a frequent cause of missed or lost workdays due to disability. The pain of LBP often doesn't go away for many years, which can diminish an individual's overall quality of life. LBP is a common cause of chronic pain. Although the exact cause of LBP is not understood, research shows that LBP has a genetic basis.

Anonymous Patient Answer

What are common treatments for low back pain?

Low back pain has a wide range of medical and nonmedical treatment options. Most patients find relief of their symptoms with medical treatments before proceeding to a surgical intervention, such as fusion, decompression, or a more conservative approach such as rest, exercise modification, epidural steroid injections, and anti-inflammatory drugs. Patients who are not sufficiently responding to medical treatment may benefit from a surgical technique like lumbar stabilization, microdiscectomy, or spinal fusion. The use of nonsurgical treatments, such as exercise modification, epidural steroid injections, anti-inflammatory drugs, and physical therapy, is growing in the last decade and remains quite common.

Anonymous Patient Answer

Can low back pain be cured?

Patients with chronic LBP reported their pain as more intense but equally negatively affecting their life than healthy individuals with non-LBP. The presence of moderate to severe LBP in these patients was not associated with a statistically significant improvement in their VAS score at one-, three- and five-year follow-up.

Anonymous Patient Answer

How serious can low back pain be?

Despite the common perception that LBP is chronic, the majority of patients experience resolution following some form of treatment, although often in a protracted, chronic, and disabling form. LBP severity decreases with advancing age, but patients age 60+ remain relatively resilient. Clinical prediction models are needed to identify patients at risk of persistent LBP and to identify those most likely to benefit from interventions.

Anonymous Patient Answer

Has brief pain teleconsult proven to be more effective than a placebo?

A brief teleconsult has enabled a clinician in a resource constrained region of Australia to be effective in helping patients and their carers cope with their pain over a 6-week period.

Anonymous Patient Answer

Does low back pain run in families?

Findings from a recent study suggest that a large portion of LBP is attributable to familial and environmental influences. Future longitudinal studies should examine the mechanisms underlying these relationships and the implications of these familial factors on LBP prevention efforts.

Anonymous Patient Answer

What is the average age someone gets low back pain?

We are in a 'golden age' of low back pain medicine, and we are in a similar situation to the 'antisynthetase syndrome' of rheumatoid arthritis being the earliest back-pain syndrome.

Anonymous Patient Answer

How does brief pain teleconsult work?

Pain knowledge and understanding can be improved after the teleconsult. Pain knowledge and understanding can also improve after consultation with a nurse. The increased pain knowledge and understanding will likely benefit patients' pain management. Data from a recent study support the continued development and use of brief pain teleconsultation for improving patients' pain management.

Anonymous Patient Answer

Does brief pain teleconsult improve quality of life for those with low back pain?

The brief telephone intervention based on the Brief Pain Inventory (BPI) as the only assessment tool significantly improves perceived quality of life for those with low [back pain](https://www.withpower.com/clinical-trials/back-pain).

Anonymous Patient Answer
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